Search Results

Amsel Endo Occluder device is an endoscopic ligating clips, which is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

Amsel Endo Occluder device is an endoscopic ligating clip applier that is pre-loaded with four sterile ligating clips. Amsel Endo Occluder device is intended to be used during endoscopic procedures (such as Laparoscopic procedures), for permanent secure occlusion of blood vessels and ductal structures. The device is a mechanical occlusion clip that when deployed transfixes the target vessel while clamping it shut. Amsel Endo Occluder contains two main components: Ligating (Occluder) Clips and Applier (device delivery).

Here's a summary of the acceptance criteria and study information for the Amsel Endo Occluder device based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner for specific device functions. Instead, it states that the device was tested to demonstrate compliance with international and FDA-recognized consensus standards and FDA guidance documents, and that it "Meets the acceptance criteria and is adequate for its intended use and specifications."

The provided information focuses on the type of tests conducted rather than specific numerical acceptance criteria and performance outcomes.

2. Sample Size Used for the Test Set and Data Provenance:

The document states that "Preclinical in-vivo tests, including acute and chronic tests, were conducted." However:

• Specific sample sizes for these in-vivo tests are not provided in the summary.
• Data provenance (e.g., country of origin, retrospective or prospective) for the test set is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The summary focuses on preclinical testing and does not mention the involvement of experts for establishing ground truth as typically seen in clinical device evaluations involving human diagnosis or interpretation.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for the preclinical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Amsel Endo Occluder device did not require clinical studies to support equivalence." Biomedical devices like ligating clips are often cleared based on non-clinical performance and substantial equivalence to predicate devices, rather than comparative clinical efficacy studies with human readers.

6. Standalone Performance Study (Algorithm Only):

This section is not applicable as the Amsel Endo Occluder device is a mechanical medical device (ligating clip applier and clips), not an AI/algorithm-driven device.

7. Type of Ground Truth Used:

For the preclinical in-vivo tests, the ground truth was based on demonstrating the safety and effectiveness of occlusion performance. This would likely involve direct observation, measurement, and pathological analysis of the ligated vessels/structures in animal models or cadaveric tissue.

8. Sample Size for the Training Set:

This information is not applicable as the device is not an AI/algorithm that requires a training set. The "training set" concept is typically for machine learning models.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reason as above (not an AI/algorithm).

Ask a specific question about this device

The Amsel Occluder Device is intended for use in open general surgery procedures on tubular structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter.

The Amsel Occluder Device involves the implantation of a mechanical occlusion device that penetrates into and through the target vessel structure and when compressed and locked, clamps the vessel shut.

The device consists of a metallic clip construct comprised of two compression components and an interlocking implant rod that when compressed together as a unit and locked on either side of a vessel results in occlusion. The delivery device consists of a hand held syringe-like device loaded with the components of the implant construct. The device is for use in general surgical procedures. Once positioned correctly, the occlusion construct is actuated through a series of semiautomatic steps resulting in the two components becoming compressed on either side of the vessel and locked together to occlude the vessel. Once occlusion is achieved, the delivery system, which is mechanically locked to the implant rod, is detached from the implant and the needle is withdrawn leaving the occlusion construct implanted, permanently occluding the vessel.

The provided text does not contain detailed acceptance criteria and the results of a study proving the device meets those criteria in a format that allows for a direct table as requested. The text describes a 510(k) submission for the Amsel Occluder Device, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria of the new device.

However, based on the information provided, I can extract and infer some points regarding performance characteristics and testing without presenting a formal table of acceptance criteria and reported performance, as these specific quantifiable metrics are not explicitly stated for acceptance.

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document in a quantifiable table format for the Amsel Occluder Device's acceptance criteria. The document outlines the types of performance tests conducted to demonstrate safety and effectiveness and substantial equivalence to predicate devices. It states that "All testing performed demonstrated that the Amsel Occluder is a safe and effective device for vessel and tubular structure occlusion and is considered substantially equivalent to its predicate devices."

The following are performance characteristics that were verified or evaluated. While these imply underlying acceptance criteria, the specific quantitative targets and results against those targets for the Amsel device itself are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated in terms of number of devices or cases for each specific test. The animal study mentions evaluating occlusion performance in "arteries and veins 2.0mm to 7.0mm".
• Data Provenance: The general nature of the pre-clinical tests and animal studies suggests these were conducted in a controlled, prospective manner. The document does not specify the country of origin of the data, but the manufacturer is Amsel Medical Corp. (Cambridge, MA, USA) and the contact person is in Providence, RI, USA, while another contact is in Kfar-Saba, Israel. This suggests testing could have occurred in either region or elsewhere.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• The document does not specify the number or qualifications of experts used to establish ground truth for the test set. For an animal study, typically veterinary surgeons and pathologists would be involved, but details are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• The document does not specify any adjudication method for the test set results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not applicable/provided. The Amsel Occluder Device is a medical implant (a ligating clip), not an AI diagnostic or assistance tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance would not be relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This information is not applicable/provided. As above, the device is a mechanical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the animal study, performance aspects like "occlusion performance" and "histology" were evaluated. This implies that pathology would be a key component of establishing ground truth for the histological analysis, along with direct observation and possibly pressure measurements (holding pressure evaluation) for occlusion performance.
• For bench testing, the ground truth would be based on engineering specifications and measurements (e.g., force, distance, corrosion absence).

8. The sample size for the training set

• This information is not applicable/provided. The Amsel Occluder is a mechanical device, not an algorithm that requires a training set in the machine learning sense. The "training set" for its development would be iterative design and testing, not a data set for model training.

9. How the ground truth for the training set was established

• This information is not applicable/provided for the same reason as point 8.

Ask a specific question about this device